PDS Biotech Updates Business and Q1 2024 Financials

PDS Biotechnology Corporation, a late-stage immunotherapy company, recently shared a business update alongside its financial performance for the first quarter of 2024. The company is known for its focus on transforming cancer treatment and the development of infectious disease vaccines.

Recent Developments

On May 8, 2024, PDS Biotech hosted a Key Opinion Leader event featuring experts in head and neck squamous cell cancer (HNSCC). They discussed the latest positive results from the VERSATILE-002 Phase 2 clinical trial, which evaluates the combination of Versamune® HPV and KEYTRUDA® (pembrolizumab) for recurrent or metastatic HNSCC. The trial's updated data revealed that the median overall survival for patients was 30 months, significantly higher than the 7-18 months typically seen with immune checkpoint inhibitors. The primary endpoint of best overall response (BOR) was achieved, with a BOR by investigator assessment of 34% and 48% for different Combined Positive Scores (CPS). Moreover, the progression-free survival was 6.3 months for CPS≥1 and 14.1 months for CPS≥20, surpassing the 2-3 months usually observed with other treatments.

The combination therapy of Versamune® HPV and pembrolizumab demonstrated a durable response and was well tolerated by patients. PDS Biotech has also announced a new clinical strategy involving a two-part registrational trial focused on the triple combination of Versamune® HPV, PDS01ADC, and pembrolizumab as a first-line treatment for HPV16-positive recurrent or metastatic HNSCC. PDS01ADC, an investigational tumor-targeting IL-12-fused antibody-drug conjugate, has shown promise in earlier studies.

Part one of this trial will focus on dose optimization, with safety and objective response rate as the data readouts. The second part will be a randomized trial with overall survival as the primary endpoint. Additionally, PDS Biotech has bolstered its management team by appointing Stephan Toutain as Chief Operating Officer, bringing extensive operational and commercial expertise.

Versamune® Platform Intellectual Property

PDS Biotech has also seen significant advancements in its intellectual property portfolio. The company received patents from the Israel Patent Office and IP Australia, extending the protection of its Versamune® platform through December 2038 and November 2036, respectively. The patents cover methods and compositions involving cationic lipids for stimulating type I interferon genes and enhancing antigen processing and presentation ex-vivo in dendritic cell therapy.

First Quarter 2024 Financial Results

For the first quarter ending March 31, 2024, PDS Biotech reported a net loss of approximately $10.6 million, or $0.30 per share, compared to a net loss of $9.7 million, or $0.32 per share, for the same period in 2023. The increase in the net loss was attributed to higher operating and net interest expenses. Research and development expenses rose to $6.7 million, primarily due to increased costs in clinical studies and medical affairs. However, general and administrative expenses slightly decreased to $3.4 million. Overall, total operating expenses reached $10.1 million, up from $9.4 million in the previous year. Net interest expenses increased to $0.5 million.

As of March 31, 2024, the company had cash and cash equivalents totaling approximately $66.6 million.

About PDS Biotechnology

PDS Biotechnology is dedicated to advancing immunotherapy treatments for cancer and developing vaccines for infectious diseases. The company plans to initiate a pivotal clinical trial in 2024 for its lead program targeting advanced HNSCC. This program features a combination of the IL-12 fused antibody drug conjugate PDS01ADC and the T-cell activator Versamune® HPV, used alongside a standard immune checkpoint inhibitor. The combination has shown promising results in tumor shrinkage and survival, indicating favorable tolerability.

The company's investigational approach aims to disrupt tumor defenses while generating targeted killer T-cells. Clinical trials involving over 350 patients have validated the potential of these platforms. PDS Biotech's Infectimune® based vaccines have also demonstrated strong immune responses in pre-clinical studies.

PDS Biotechnology continues to innovate in the field of immunotherapy, with ongoing research and development aimed at improving cancer treatment outcomes.

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